Obtaining the informed consent of women, including those who are pregnant or nursing, usually presents no special problems. In some cultures, however, women's rights to exercise self-determination and thus give valid informed consent are not acknowledged. In such cases, women should not normally be involved in research for which societies that recognize these rights require informed consent. Nevertheless, women who have serious illnesses or who are at risk of developing such illnesses should not be deprived of opportunities to receive investigational therapies when there are no better alternatives, even though they may not consent for themselves. Efforts must be made to let such women know of these opportunities and to invite them to decide whether they wish to accept the investigational therapy, even though the formal consent must be obtained from another person, usually a man. Such invitations may best be extended by women who understand the culture sufficiently well to discern whether prospective recipients of investigational therapies genuinely wish to accept or reject the therapy.

REFERENCES

Council for International Organizations of Medical Sciences in collaboration with the World Health Organization. 1993. International Ethical Guidelines for Biomedical Research Involving Human Subjects. Geneva: WHO.

Newton, L. 1984 Agreement to participate in research: Is that a promise? IRB: A Review of Human Subjects Research 6(2):7–99.

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